Table 2.
Trial | Design | Intervention | Median recurrence-free survival (months) | Pathologic complete response | Grade 3–4 adverse events |
---|---|---|---|---|---|
Trials with neoadjuvant and adjuvant targeted therapy | |||||
NCT02231775 Amaria et al. 53 |
Phase II (n = 21) |
Arm A: Upfront surgery with consideration of adjuvant therapy Arm B: Neoadjuvant dabrafenib and trametinib for 8 weeks followed by adjuvant dabrafenib and trametinib for 44 weeks |
Arm A: 2.9 (p < 0.0001) Arm B: 19.7 |
Arm A: NA Arm B: 50% | Arm A: NA Arm B: 15% |
NCT01972347 Long et al. 54 |
Phase II (n = 35) |
Neoadjuvant dabrafenib and trametinib for 12 weeks, adjuvant therapy for 40 weeks | 23.3 | 49% | 29% |
Trials with only neoadjuvant arms | |||||
NTR4654 Blankenstein et al. 35 |
Phase II (n = 20) |
Neoadjuvant dabrafenib and trametinib for 8 weeks in patients with unresectable disease followed by surgery if resectable | 9.9 | 28.6%, | 19% |